US11690550B2ActiveUtilityA1

System and method for an ingestible physiological monitor

64
Assignee: MASSACHUSETTS GEN HOSPITALPriority: Jul 26, 2017Filed: Jul 20, 2018Granted: Jul 4, 2023
Est. expiryJul 26, 2037(~11 yrs left)· nominal 20-yr term from priority
A61B 5/086A61B 5/6873A61B 5/746A61B 5/0537A61B 5/14552A61B 5/0809A61B 5/02444A61B 5/42A61B 5/68A61B 5/073A61B 5/285A61B 5/361A61B 5/02055A61B 2562/0215A61B 2562/162A61B 5/01A61B 5/021A61B 5/0215A61B 5/024A61B 5/375A61B 5/318A61B 5/688
64
PatentIndex Score
1
Cited by
21
References
25
Claims

Abstract

In accordance with some non-limiting examples of the disclosed subject matter, an ingestible system configured to acquire physiological information from an interior of a subject is provided, comprising a substrate and at least one physiological sensor. The at least one “physiological sensor can be coupled to the substrate and configured to capture physiological data from at least one of an internal area or an orientation in a digestive tract of the subject. The system can include a controller coupled to the substrate and configured to receive the physiological data and prepare the physiological data for one of transmission from the subject or analysis of the physiological data. The substrate, including the at least one physiological sensor and the controller coupled thereto can be configured to self-orient within the digestive tract of the subject, during ingestion of the system by the subject.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. An ingestible system configured to acquire physiological information from an interior of a subject, the system comprising:
 a substrate; 
 at least one physiological sensor coupled to the substrate and configured to capture physiological data from a digestive tract of the subject, the at least one physiological sensor includes a first electrode and a second electrode; 
 a controller coupled to the substrate and configured to receive the physiological data and prepare the physiological data for one of transmission from the subject or analysis of the physiological data; and 
 wherein the substrate, with the at least one physiological sensor and the controller coupled thereto is configured to self-orient within the digestive tract of the subject during ingestion of the system by the subject to orient the at least one physiological sensor in the at least one of the internal area or the orientation in the digestive tract of the subject. 
 
     
     
       2. The system of  claim 1  wherein the at least one physiological sensor and the controller are coupled on a common side of the substrate. 
     
     
       3. The system of  claim 2  further comprising a mucoadhesive arranged on a side of the substrate that is opposite from the common side to couple the system to the at least one of the internal area or the orientation in the digestive tract of the subject after the substrate self-orients. 
     
     
       4. The system of  claim 1  further comprising a communication circuit configured to receive the at least one of the physiological data or analyzed physiological data from the controller to communicate externally from the subject. 
     
     
       5. The system of  claim 1  further comprising a housing surrounding the substrate, the at least one physiological sensor, and the controller. 
     
     
       6. The system of  claim 5  wherein the housing includes a capsule that is configured to disintegrate after being subjected to the digestive tract. 
     
     
       7. The system of  claim 6  wherein the substrate is adjustable between a folded position and an extended position and wherein the substrate is in the folded position within the capsule and moves to the extended position after the capsule decomposes to self-orient the substrate in the digestive tract. 
     
     
       8. The system of  claim 1  wherein the at least one physiological sensor includes at least one of:
 a first electrode, a second electrode, or a pulse generator, and wherein the pulse generator is configured to emit current pulses through the first or second electrode, to perform impedance measurements across the first electrode and the second electrode; 
 at least one of a first electrode and a second electrode configured to capture electrocardiogram signals; 
 a pulse oximeter configured to acquire an oxygen saturation measurements; or a temperature sensor configured to measure an internal temperature of the subject. 
 
     
     
       9. The system of  claim 1  wherein the internal area includes an intestine of the subject. 
     
     
       10. The system of  claim 1  further comprising an enteric coating covering the at least one physiological sensor and the controller to protect against an acidic pH environment and allows dissolving in a neutral pH environment. 
     
     
       11. The system of  claim 1  wherein the at least one physiological sensor includes:
 a first electrode, a second electrode, or a pulse generator, and wherein the pulse generator is configured to emit current pulses through the first or second electrode, to perform impedance measurements across the first electrode and the second electrode; 
 at least one of a first electrode and a second electrode configured to capture electrocardiogram signals; 
 a pulse oximeter configured to acquire an oxygen saturation measurements; and 
 a temperature sensor configured to measure an internal temperature of the subject. 
 
     
     
       12. The system of  claim 1  wherein the at least one physiological sensor includes:
 a pulse oximeter in communication with the controller for capturing a blood oxygenation parameter or a respiration signal; and 
 an electrocardiogram in communication with the controller for capturing an electrical signal of a heart. 
 
     
     
       13. The system of  claim 12 , wherein the at least one physiological sensor further comprises:
 a first electrode, a second electrode, or a pulse generator, and wherein the pulse generator is configured to emit current pulses through the first or second electrode, to perform impedance measurements across the first electrode and the second electrode; and 
 the first electrode and the second electrode in electrical communication with the electrocardiogram. 
 
     
     
       14. The system of  claim 1  wherein the substrate includes a plurality of mechanical links integrally formed in the substrate, the mechanical links separating at least one of the controller, and the at least one physiological sensors. 
     
     
       15. The system of  claim 14  wherein the mechanical links comprise a biogalvanic material electrically connected to the controller, the controller executing at least a portion of a computer program to cause the mechanic links to degrade. 
     
     
       16. A method for internal monitoring, the method comprising:
 ingesting an ingestible system, the ingestible system comprising a capsule and a physiological monitor, the physiological monitor comprising:
 a substrate; 
 at least one physiological sensor coupled to the substrate; 
 a controller coupled to the substrate and configured to receive physiological data and prepare the physiological data for one of transmission from a subject or analysis of the physiological data; 
 wherein the substrate of the physiological monitor is folded, such that the physiological monitor is bent over itself so that one part of the physiological monitor covers another part of the physiological monitor thereby creating a folded physiological monitor that is placed in the capsule to be ingested by a subject; 
 
 dissolving the capsule in a portion of an intestine of the subject to release the folded physiological monitor in the portion of the intestine; and 
 unfolding the folded physiological monitor in the portion of the intestine. 
 
     
     
       17. The method of  claim 16  further comprising self-orienting the physiological monitor in the portion of the intestine, such that a first surface of the physiological monitor faces a wall of the portion of the intestine. 
     
     
       18. The method of  claim 16 , wherein a first surface of the physiological monitor includes a mucoadhesive, and further comprising adhering the first surface of the physiological monitor to the wall of the portion of the intestine. 
     
     
       19. The method of  claim 16  further comprising the controller transmitting an alert to an external device, based on a physiological parameter. 
     
     
       20. The method of  claim 16  wherein the physiological monitor further comprises:
 a first electrode, a second electrode, or a pulse generator, and wherein the pulse generator is configured to emit current pulses through the first or second electrode, to perform impedance measurements across the first electrode and the second electrode; 
 at least one of a first electrode and a second electrode configured to capture electrocardiogram signals; 
 a pulse oximeter configured to acquire an oxygen saturation measurements; and 
 a temperature sensor configured to measure an internal temperature of the subject. 
 
     
     
       21. The method of  claim 20  wherein an impedance waveform is generated from the impedance measurements, the impedance waveform indicating a respiratory signal. 
     
     
       22. The method of  claim 16  wherein the capsule includes an enteric coating, such that when the capsule is ingested, the capsule remains stable in an acidic pH environment, and the capsule dissolving in a neutral pH environment. 
     
     
       23. An ingestible system comprising:
 a substrate; and 
 a physiological sensor coupled to the substrate, the physiological sensor being at least one of a pair of electrodes, or a pulse oximeter; 
 wherein the ingestible system is configured to adhere to a lining of an intestine of a subject when the ingestible system contacts the lining of the intestine of the subject; and 
 wherein when the ingestible system is adhered to the lining of the intestine of the subject, the physiological sensor is configured to capture physiological data of the subject, the physiological data including at least one of an ECG signal, an impedance signal, a respiratory signal, or a blood oxygenation parameter. 
 
     
     
       24. The ingestible system of  claim 23 , wherein the substrate is flexible and is planar. 
     
     
       25. The ingestible system of  claim 23 , further comprising a controller coupled to the substrate, the controller being configured to:
 receive, from the physiological sensor, the physiological data; and 
 transmit the physiological data to an external device.

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